BIOE 8630 - Reg & Clinical Aff for Med Dev

Institution:

Clemson University

Subject:

Bioengineering

Description:

Addresses the regulatory pathway and clinical research process required for medical device commercialization. Lectures focus on the roles and responsibilities of regulatory and clinical affairs departments, clinical trial design, protocol writing, data collection and reporting, quality assurance in clinical trials, and risk management.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.clemson.edu

Phone Number:

(864) 656-4636

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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